Rx Product News
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Epiduo Gel
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Galderma Laboratories LP (Fort Worth, TX)
Indication:
January 6, 2009—Galderma Laboratories announced
the availability of Epiduo (adapalene and benzoyl peroxide)
Gel 0.1%/2.5%. This product represents the
first and only, once-daily, topical acne treatment that
combines the well-tolerated retinoid adapalene and
benzoyl peroxide, an antimicrobial with no evidence of
promoting bacterial resistance. Epiduo Gel is indicated
for the topical treatment of acne vulgaris in patients 12
years of age and older. Patients should apply the gel
in a thin film to affected areas of the face and/or trunk
once daily after washing; patients should use a peasized
amount for each area of the face (eg, forehead,
chin, each cheek). The eyes, lips, and mucous membranes
should be avoided during application.
Dosage Form:
Each gram of Epiduo Gel contains 1 mg (0.1%) adapalene
and 25 mg (2.5%) benzoyl peroxide in an
aqueous-based gel.
For More Information:
www.galdermaUSA.com
Latisse
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Allergan Inc (Irvine, CA)
Indication:
December 26,
2008—Allergan Inc
announced FDA
approval of Latisse
(bimatoprost ophthalmic
solution) 0.03%
as a novel treatment for hypotrichosis of the eyelashes
(having inadequate or not enough eyelashes).
Latisse is the first and only science-based treatment
approved by the FDA to enhance eyelash prominence
as measured by increases in length, thickness,
and darkness of eyelashes. Bimatoprost, the active
pharmaceutical ingredient in Latisse, is a structural
prostaglandin analog—a lipid compound derived from
fatty acids designed to bind to prostaglandin receptors.
The solution is intended for use on the skin of
the upper eyelid margins at the base of the eyelashes
(not the lower eyelid).
Dosage Form:
Bimatoprost ophthalmic solution 0.3 mg/mL
For More Information:
www.latisse.com
Norditropin
 |
Novo Nordisk Inc (Princeton, NJ)
Indication:
November 4, 2008—The FDA approved an
additional indication for Norditropin (somatropin
[rDNA origin] injection) for the treatment of
short stature in children born small for gestational
age with no catch-up growth by 2 to 4
years of age. Children born with this condition
now have a new treatment option to help them
grow to a normal height. It also is indicated for
the treatment of children with short stature
associated with Noonan syndrome, treatment
of children with short stature associated with
Turner syndrome, and treatment of children
with growth failure due to inadequate secretion
of endogenous growth hormone. Norditropin
also is indicated for replacement of endogenous
growth hormone in adults with either adult- or
childhood-onset growth hormone deficiency.
Dosage Form:
Cartridges are available for use with the corresponding
NordiPens or preloaded in the Norditropin
NordiFlex pens—5 mg/1.5 mL: cartridge and
Norditropin NordiFlex pen; 10 mg/1.5 mL: Norditropin
NordiFlex pen only; 15 mg/1.5 mL: cartridge and
Norditropin NordiFlex pen.
For More Information:
www.novonordisk-us.com
Moxatag
 |
MiddleBrook Pharmaceuticals Inc (Westlake, TX)
Indication:
January 7, 2009—MiddleBrook
Pharmaceuticals Inc announced
that the launch of Moxatag (amoxicillin
extended-release) Tablets,
775 mg, will begin in March. Moxatag is the first and
only once-a-day amoxicillin product indicated for the
treatment of tonsillitis and/or pharyngitis secondary
to Streptococcus pyogenes in adults and pediatric
patients aged 12 years or older. The formulation
of Moxatag consists of 1 immediate-release and 2
delayed-release components of amoxicillin. These
3 components are combined in a specific ratio to
prolong the release of amoxicillin from Moxatag,
compared with currently available immediate-release
amoxicillins.
Dosage Form:
Tablets: 775 mg
For More Information:
www.middlebrookpharma.com
PreNexa
 |
Upsher-Smith Laboratories Inc (Minneapolis, MN)
Indication:
December 3,
2008—Upsher-Smith
Laboratories announced
its plans to market
PreNexa, the first and only single-gel capsule prenatal
vitamin with the most plant-based docosahexanoic
acid (DHA, 265 mg) for women considering pregnancy,
pregnant women, and mothers who are breastfeeding.
PreNexa is a once-daily single-gel capsule
indicated to provide vitamin/mineral and plant-based
DHA supplementation throughout pregnancy, during
the postnatal period for both lactating and nonlactating
mothers, and throughout the childbearing years.
Dosage Form:
One soft gel capsule daily or as directed by a physician
For More Information:
www.prenexa.com
Prezista
 |
Tibotec Therapeutics/Division of Ortho Biotech Products, LP (Bridgewater, NJ)
Indication:
November 19, 2008—Tibotec
Therapeutics announced the
launch of a 400-mg Prezista (darunavir)
tablet. Prezista is a protease
inhibitor indicated for the
treatment of HIV infection in adult patients. Prezista
also is indicated for the treatment of HIV infection
in pediatric patients 6 years of age and older. The
product must be coadministered with ritonavir and
with other antiretroviral agents. In addition, the FDA
recently granted approval for an expanded indication
for Prezista once-daily dosing as part of an HIV combination
therapy in treatment-na?ve adults.
Dosage Form:
Tablets: 75, 300, 400, and 600 mg
For More Information:
www.prezista.com
877-REACH-TT (877-732-2488)
Zolpimist
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NovaDel Pharma Inc (Flemington, NJ)
Indication:
December 22, 2008—NovaDel Pharma Inc announced
that Zolpimist (zolpidem tartrate) 5 mg and 10 mg
Oral Spray was approved by the FDA for the shortterm
treatment of insomnia characterized by difficulties
with sleep initiation. Zolpimist contains zolpidem
tartrate, the same active ingredient as Ambien. Due
to its rapid onset of action, patients should take
Zolpimist immediately before bedtime and be prepared
to get a full night's sleep (7-8 hours).
Dosage Form:
Oral spray: 5 and 10 mg
For More Information:
www.novadel.com
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